Randomised Controlled Clinical Trial of Cognitive Rehabilitation in Multiple Sclerosis (REACTIV)
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|ClinicalTrials.gov Identifier: NCT01207856|
Recruitment Status : Completed
First Posted : September 23, 2010
Last Update Posted : February 9, 2016
Despite the need for cognitive rehabilitation, there is a paucity of well-designed research studies to investigate treatment approaches or their effectiveness in MS. Most of published studies suffer from significant methodological flaws including small sample size, short follow-up periods, and lack of specific outcome criteria to determine improvement. O'Brien et al. (2008) recently reviewed 16 studies of cognitive rehabilitation designed to persons with MS and found only 4 class I studies and only one class I study of rehabilitation of attention deficits. Methodologically rigorous research is needed to confirm the preliminary results reported by these studies and determine the effectiveness and efficacy of cognitive rehabilitation interventions in attention deficits in MS. O'Brien et al. listed limitations found in previous studies that must be addressed in future studies. The present study was designed according to these recommendations. It is a randomized, controlled study, in parallel groups, evaluator blinded.
Number of participants: 25 RRMS patients in the active group, 25 RRMS patients in the control group and 25 healthy subjects.
The protocol will be proposed to RRMS patients AFFILIATED TO FRENCH SOCIAL SECURITY referred to the investigators center by practicing neurologists and fulfilling the inclusion criteria for screening.
Patients will be randomised between two groups. The active group (25 patients) will be treated by rehabilitation. Individual rehabilitation procedures will be focused on attention, executive functions and IPS. The program will be tailored to each patient cognitive status depending on the impairments identified during the initial assessment while maintaining a systematic work on attention and executive functions. A total of 50 sessions lasting one hour at a rate of 3 sessions per week for a total period of 4 months will be proposed. Patients randomized in the other group will participate to group session every week without specific cognitive rehabilitation. 25 healthy control subjects (group C), matched to patients for education, gender and age with patients of groups A/B will have the same evaluation procedures than patients.
Evaluation will be performed at baseline, after 4 months (end of treatment period) and after 8 months. Evaluation will include clinical testing, cognitive battery (paper/pencil and computer tests), cognitive ecological evaluation (Computer test of attention in a virtual reality environment and driving test on a driving simulator), questionnaires about daily life and MRI (fMRI and MRI). All patients and healthy subjects will undergo the fMRI protocol using a paradigm previously published by the investigators group (Bonnet et al., 2009): Go/No-go paradigm with increasing difficulty during four successive conditions (the Tonic Alertness task, Go/No-go (IG), reversal Go/No-go (RG), and complex Go/No-go (CG). In a previous study the investigators observed compensatory activation in MS patients as compared to healthy controls for the three first conditions and a saturation of compensatory processes for the more complex. In the present study, the investigators hypothesize that a similar pattern will occur at baseline and that cognitive rehabilitation will improve brain compensation at the fourth level of complexity.
|Condition or disease||Intervention/treatment||Phase|
|Multiple Sclerosis Cognitive Rehabilitation||Behavioral: specific cognitive rehabilitation Behavioral: non specific cognitive rehabilitation Other: no intervention||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||65 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Randomised Controlled Clinical Trial of Cognitive Rehabilitation in Multiple Sclerosis and Assessment by Neuroimaging|
|Study Start Date :||May 2011|
|Actual Primary Completion Date :||July 2015|
|Actual Study Completion Date :||February 2016|
Active Comparator: group A
specific cognitive rehabilitation
Behavioral: specific cognitive rehabilitation
Individual rehabilitation procedures will be focused on attention, executive functions, IPS and working memory. The program will be tailored to each patient cognitive status depending on the impairments identified during the initial assessment while maintaining a systematic work on attention and executive functions. A total of 50 sessions lasting one hour at a rate of 3 sessions per week for a total period of 4 months will be proposed. Sessions will include varied exercises according to complexity and presentation modality, using computerized and "paper-and-pencil" tasks and metacognitive training. Work will be progressive, depending on the progresses achieved (increase complexity and intensity of the exercises according to success at the previous level of exercises).
|Active Comparator: Groupe B : non specific rehabilitation||
Behavioral: non specific cognitive rehabilitation
A total of 50 sessions lasting one hour at a rate of 3 sessions per week for a total period of 4 months will be proposed by group composed to 5 patients
group C for MRI, neuropsychological and ecological assessments
Other: no intervention
- Comparison between groups concerning the z cognitive global executive z score . [ Time Frame: after 4 months (M4) ]
- Comparison of brain activation in the treated group versus control group at the fourth condition. [ Time Frame: 4 and 8 months ]
- Comparison between groups concerning the z score of the SDMT [ Time Frame: 4 and 8 months ]
- Comparison between groups of the daily-life cognitive questionnaire scores [ Time Frame: at M4 and M8 ]
- Comparison between groups concerning the z cognitive global executive z score [ Time Frame: 8 months ]
- Clinical Global impression of patients [ Time Frame: 4 and 8 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01207856
|Service de Neurologie - Pôle des Neurosciences Cliniques, CHU de Bordeaux.|
|Bordeaux, France, 3300|
|Study Director:||Bruno Brochet, Md PhD||UH Bordeaux|